Application 078306

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	No	No
002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	200MG	No	No
003	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078306-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09
A078306-002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09
A078306-003	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078306-002	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078306-003	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078306-002	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078306-003	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078306-002	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078306-003	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078306-002	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078306-003	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078306-002	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078306-003	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078306-002	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078306-003	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078306-002	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078306-003	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078306-002	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078306-003	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078306-002	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078306-003	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078306-002	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078306-003	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078306-002	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078306-003	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078306-002	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078306-003	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078306-002	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078306-003	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078306-001	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2007-08-09	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078306-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078306-002	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A078306-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078306-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078306-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078306-002	AB	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	df79ee3a-f0ed-1cc7-e053-2995a90af97f	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Lifestar Pharma LLC	df77b8d1-1d2b-4fea-a1e9-153bd25008a6	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Hospira, Inc.	1c993365-1b62-4524-e781-d307f28f63bc	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	REMEDYREPACK INC.	ce9ab27a-e03b-4e40-a0e0-b586cd75dead	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Somerset Therapeutics, LLC	50131bbc-ad43-4708-946f-e4000828137c	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Safecor Health LLC	bf7b5037-7355-4788-b17b-323c18a5aee7	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Henry Schein, Inc.	4f6ae43f-c28a-4eac-9b19-8b5d0c12dfaa	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	REMEDYREPACK INC.	5dc5f087-c8da-4ed0-b532-ae44508958aa	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	e36e485f-fbed-4e30-9a63-984931f2e54e	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	4dcc46d8-76b0-fbd4-e063-6294a90ad9e6	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Hospira, Inc.	70057a53-ca29-4848-ab3d-5e691e2a14a3	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Zydus Lifesciences Limited	051392d3-8ec1-450c-8c38-791d4ef1a2db	2026-04-09		Name fallback brand name: Verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	e19ab8d8-dae5-489d-9805-7e7407bea06d	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: Verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	4dcb137e-b01a-eb3a-e063-6294a90aaecc	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	1de6ad5c-942e-4381-b01f-e5e63bbf72ef	2026-03-10	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	A-S Medication Solutions	e07b3574-9259-4f64-a9ae-f4e0e64800b6	2026-03-07	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Cadila Pharmaceuticals Limited	5501208c-aa2b-47aa-89f7-87f4d4a73fd0	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	AvKARE	a32f346e-71cf-cc11-e053-2a95a90ae88c	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3c215e6c-d85a-4102-a1c2-f00fa3169a55	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9d529fe3-7b5c-4dde-9a8c-440a969df359	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6201	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6201	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6201	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6202	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6202	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6202	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6203	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6203	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9141	ORIG	2007-08-14